Project Summary The goal of the phase I SBIR project proposed by My Music Machines, Inc. (DBA Jamboxx, Inc.) is to create an electronic gaming device for diaphragmatic breathing (aka deep breathing) instruction for physical therapy, using wearable sensors synched to an immersive virtual reality (VR) video game that can be played on a smartphone device with a VR headset. The game will guide users through the proper breathing technique while providing biofeedback to optimize their performance. The device intends to help engage patients with lower back pain in an otherwise monotonous therapy technique, while helping them to relax, and ensuring that they are performing the technique properly when they are not under the observation of a physical therapist. Breath therapy has been shown to be an effective non-pharmacological approach to the treatment of chronic lower back pain and a variety of other musculoskeletal imbalances. Recent studies have found VR to be an effective method to manage pain and distress during medical procedures, acting as a non-pharmacological form of analgesia and resulting in reduction in opioid dosing. With the current opioid crisis in the United States, there is a recognized need for the development and implementation of non-pharmacological pain management and pain reduction therapies like this that can be prescribed as a first course of treatment. The long term goal of the proposed project is to create the first virtual reality gaming device for breathing therapy for the treatment of lower back pain. To do this, Jamboxx, Inc. has partnered with Dr. Jason Gagon PT, DPT, CSCS, head of Albany Medical Center?s outpatient physical therapy program. In phase I, a series of two wearable sensors that can be positioned on the users abdomen and chest will be prototyped and programmed to communicate with a smartphone device. A corresponding smartphone app will be created that contains a VR setting and games to guide users through the proper diaphragmatic breathing technique while providing audio and visual feedback. The hardware and associated games will be play tested throughout development to determine usability, user engagement, and entertainment value. Finally the device will be pilot tested with lower back pain patients undergoing physical therapy at an outpatient clinic under the guidance of a therapist to determine usability, and the ability of the device to properly teach the diaphragmatic breathing technique to this patient population. Successful completion of Phase I will result in the development of a tested and validated VR system for the treatment of lower back pain that is ready for clinical trial in Phase II. Since the limitations of this targeted solicitation prohibit the testing of clinical outcomes in Phase I, the team will not attempt to determine whether the device is capable of reducing back pain, but simply to determine if it is successful in teaching the diaphragmatic breathing technique to this patient population. These early results will be used to demonstrate device feasibility, and will inform the process for developing a clinical trial to test efficacy in Phase II.